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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006528
Receipt No. R000007698
Scientific Title Multicenter phase II study of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Date of disclosure of the study information 2011/10/13
Last modified on 2016/11/16

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Basic information
Public title Multicenter phase II study of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Acronym Multicenter phase II study of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
<CCOG-1104 (C3-02)>
Scientific Title Multicenter phase II study of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Scientific Title:Acronym Multicenter phase II study of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
<CCOG-1104 (C3-02)>
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival
Key secondary outcomes One year survival rate, Overall survival, Response rate, Disease control rate, Time to treatment failure, Toxicity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 adding bi-weekly cetuximab to oral S-1 therapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Histopathologically confirmed colorectal cancer
(2) Unresectable advanced colorectal cancer patients who have failed prior oxaliplatin and irinotecan-based therapies
(3) Measurable or evaluable disease (RECIST ver.1.1.)
(4) Colorectac cancer with Kras wild type gene
(5) Age of 20 years or older
(6) ECOG performance status 0-1
(7) Alife expectancy greater than 3 months
(8) Written informed concent
(9) Adequate organ function
Key exclusion criteria (1) Patient who had treated by EGFR inhibitors
(2) Uncontrolled infection.
(3) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year.
(4) Severe lung disease.
(5) Interstitial lung disease or pulmonary fibrosis.
(6) Severe liver disease.
(7) Severe renal failure, or urinary protein (more than 2+).
(8) Previous history of severe drug-induced allergy
(9) ileus, bowel obstruction
(10) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.).
(11) History of active double cancer.
(12) Massive pleural effusion or ascites that required drainage.
(13) Brain metastasis
(14) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(15) Not appropriate for the study at the physician's assessment.

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Goro Nakayama
Organization Nagoya University Gradeate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 65,Turumaityou,Syouwaku,Nagoya city,Aichi prefecture
TEL 052-744-2250
Email goro@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norifumi Hattori
Organization Nagoya University Gradeate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 65,Turumaityou,Syouwaku,Nagoya city,Aichi prefecture
TEL 052-744-2250
Homepage URL http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
Email norifumi@med.nagoya-u.ac.jp

Sponsor
Institute Chubu Clinical Oncology Group (CCOG)
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2011 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2016 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 12 Day
Last modified on
2016 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007698

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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